510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964488Substantially Equivalent

Detachable Silicone Balloon (Dsb)

Target Therapeutics, Freemont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964488 is the FDA 510(k) clearance record for DETACHABLE SILICONE BALLOON (DSB), a class II device, cleared for Target Therapeutics on under FDA product code MZQ (Balloon, Detachable, For Neurovascular Occlusion). FDA records list 70 510(k) clearances for Target Therapeutics, from to . As of , FDA records show no recalls naming K964488.

Clearance record

Decision date
Received
(529 days to decision)
Product code
MZQ Balloon, Detachable, For Neurovascular Occlusion
Regulation
21 CFR 882.5950
Device class
Class II
Review panel
Neurology
Applicant
Target Therapeutics 47201 Lakeview Dr., Freemont CA
510(k) summary
Summary
Third party review
No

Clearances, product code MZQ

Trailing 12 months

FDA records hold no clearances under product code MZQ in the trailing twelve months.

FDA records show no clearances under product code MZQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MZQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260